Pharmaceutical

Companies in the pharmaceutical industry face the complex and expensive task of managing compliance and quality assurance in accordance with FDA & GxP regulations. The requirement for documented quality assurance means that throughout the life of a project, thousands of validation plans, protocols and reports have to be generated, and their contents updated and tracked on an ongoing basis to ensure that the necessary compliance is taking place.  The risk of non-compliance in the industry is high and could result in hefty fines and even plant closures.

Today Pharma companies use a large range of solutions from Microsoft Office for documents to EMC/Documentum, Oracle and Hummingbird for storage and document management.

The amount of time and manpower spent on complying with the regulatory guidelines is the biggest challenge in achieving and maintaining regulatory compliance in the pharmaceutical industry.

The information inside each individual document, either they are CVS compliance protocols, facility compliance protocols or CAPA protocols, is related to other individual documents. With Microsoft® Office this means controlling all this information across multiple separate documents each time anything changes.

QAvalid enables full control over the information in all of the compliance documents and is fully integrated with Microsoft® Office which guarantees that all documents in any project are always kept compliant and ready for inspection - regardless of how many physically separated documents the regulatory information is distributed across!

QAvalid for...

QAvalid for Computer System Validation (CSV)

QAvalid gives you full control over the information in all computer system validation compliance documents (URS, SRS or FS, DS, IQ, OQ, PQ, SOP etc.) and is fully integrated with Microsoft® Office which guarantees that all CVS documents in any project are always kept compliant and ready for inspection.

Computerized System Validation teaser.

Computerized System Validation brochure.

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QAvalid for Facility Commissioning and Qualification

Pharmaceutical companies typically employ significant resources (time, money, specialized personnel or consulting) to validate a current Good Manufacturing Practice (cGMP) facility.

Facility Commissioning and Qualification.

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QAvalid for Corrective Actions / Preventive Actions (CAPA)

QAvalid was developed as part of a solution to help companies manage preventive corrective action processes that are critical in mantaining compliance. QAvalid for CAPA collects data from multiple sources, manages trends, connects and automatically triggers subsystem processes to solve production issues.

Corrective Actions / Preventive Actions.

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